Amol Akhade: Landmark Advance in Gastric Cancer – Phase 3 FORTITUDE-101 Trial Positive for Bemarituzumab
Amol Akhade, Consultant Medical Oncologist at Suyog Cancer Clinics, shared a post on LinkedIn:
“Landmark Advance in Gastric Cancer: Phase 3 FORTITUDE-101 Trial Positive for Bemarituzumab. Amgen has announced that the Phase 3 FORTITUDE-101 trial has met its primary OS endpoint at interim analysis.
The study evaluated bemarituzumab plus mFOLFOX6 versus chemotherapy alone in first-line treatment of locally advanced or metastatic gastric/GEJ cancer with FGFR2b overexpression (HER2-negative).
Key Highlights: Statistically significant and clinically meaningful overall survival (OS) benefit FGFR2b+ defined as IHC 2+/3+ in ≥10% of tumor cells ~24% of gastric/GEJ adenocarcinomas qualify as FGFR2b+ Represents a first-in-class targeted therapy opportunity in this subset
Safety Profile: Despite the efficacy, ocular toxicity emerged as a notable concern:
Dry eye, keratitis, reduced visual acuity, and corneal epithelial damage These events were more frequent and more severe in the bemarituzumab arm Findings are consistent with Phase 2 and may require proactive ophthalmologic monitoring
This side-effect profile will play a key role in determining real-world uptake and treatment compliance.
Broader Context: FGFR2b is now emerging as a clinically actionable biomarker in gastric cancer, alongside HER2 and PD-L1. The results of FORTITUDE-101 support integrating routine IHC testing for FGFR2b in the diagnostic workup for advanced disease.
Additionally, new agents in development—including FGFR2b-targeted ADCs—are exploring alternative approaches that may improve the efficacy–toxicity balance in this space.
Clinical Implications:
- FGFR2b+ patients (~1 in 4) now have a promising biomarker-guided first-line option
- Ocular toxicity is real and needs early, multidisciplinary management
- FGFR2b IHC testing may soon become standard practice
- The gastric cancer landscape is shifting toward precision-driven segmentation
Are you ready to test for FGFR2b in clinic? How would you counsel patients on eye toxicity? Is this the beginning of a new biomarker era in GI oncology?”
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